Kornimate/medical-research-clean huggingface dataset:
prevention of skin cancer in high risk patients after conversion to a sirolimus-based immunosuppressive protocol

Conditions: Renal Transplant Patients at High-risk for Skin Cancer

Summary: transplant recipients have a high risk to develop skin malignancies. this effect depends on the one hand on the immunosuppressive drugs themselves and relates on the other hand on the dosage. based on the encouraging results of previous, retrospective studies on patients treated with sirolimus (srl), these patients should be switched to an immunosuppressive regime including srl, decreasing the dosage of calcineurin-inhibitors or converting from former immunosuppression. a conversion to a srl-based therapy is effective in immunosuppression and safe regarding graft and patient survival. this study was designed to assess whether a switch to a srl-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.


Eligibility criteria:
inclusion criteria: * recipients of renal allograft with current actinic keratosis i or ii or successfully treated actinic keratosis iii (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (scc), basal cell carcinoma * age 18 years and older * minimum period of 6 month after renal transplantation * stable renal function and a calculated creatinine clearance of at least 40 ml/min * written informed consent * proteinuria ≤ 800 mg/d at time of enrolment * successfully treated solid tumor (no recurrence or metastasis in the last 2 years) exclusion criteria: * current sirolimus- or everolimus- intake * instable graft function (creatinine clearance \< 40 ml/min) * graft rejection within the 3 previous months * proteinuria \> 800 mg/d * non-controlled hyperlipidemia (cholesterol \>7,8 mmol/l (300 mg/dl), triglycerides \> 4 mmol/l (350 mg/dl) * leucopenia \< 2500/nl * thrombocytopenia \< 90/nl * pregnancy or breastfeeding * women of childbearing age without highly effective contraception * known allergy to macrolides * current participation in other studies * refusal to sign informed consent form * neoplasm other than defined as inclusion criteria * all contraindications to srl (see package insert, appendix) * persons who are detained officially or legally to an official institute * acute infections (mycotic, viral or bacterial) * current intake of other substances with known nephrotoxicity * severe liver dysfunction * current intake of cy3a4-inhibitors (e.g. ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or cy3a4-inductors (rifampicin, rifabutin) * sucrose-isomaltase deficiency, fructose intolerance, glucose-galactose intolerance * azathioprine: known allergy to azathioprine or 6-mercaptopurine, severe bone marrow dysfunction, pancreatitis, vaccination with live vaccine * tacrolimus: known allergy to tacrolimus * mycophenolatmofetil: known allergy to mycophenolatmofetil, neutropenia, severe active gastrointestinal tract disease, lesch-nyhan syndrome or kelley-seegmiller syndrome, current intake of azathioprine * cyclosporine: known allergy to cyclosporine, increased intracranial pressure
risk stratification of heart failure in cardiomyopathies.

Conditions: Cardiomyopathy With Unknown Etiology

Summary: the investigators aimed to use cmr technique in helping diagnose the etiology of unknown cardiomyopathy. try to make a risk stratification of susceptible heart failure based on the extent of myocardial impairment.

cardiomyopathy is a category of multiple causes of myocardial injury in structure and function, of which unexplained cardiomyopathy was most worried by cardiologists. since the etiology confirmation sometimes still lacks of effective tools, therefore it can not be treated against etiology and may gradually developing to systolic or diastolic heart failure. the development of heart failure can be in different speeds, varying degrees, inconsistent in reversibility, and distinct response to treatment of heart failure. in "real-world", ecg , cardiac ultrasound and myocardial enzymology can not be the whole to indicate the etiology of heart failure, so a strong clinical tool in the existing auxiliary examination is urgently needed and help to assess the risk of potential heart failure, therefore a reasonable treatment time window can be proposed. the investigators aimed to use cmr technique in helping diagnose the etiology of unknown cardiomyopathy. try to make a risk stratification of susceptible heart failure based on the extent of myocardial impairment.

Eligibility criteria:
inclusion criteria: * participants with cardiomyopathy diagnosed by medical history, clinical symptoms, laboratory tests including ecg, echocardiography. * no known etiology of cardiomyopathy was confirmed. exclusion criteria: * with contraindications of magnetic resonance include: 1, participants with cardiac pacemakers and nerve stimulator; 2, participants who have done aneurysm surgery and intracranial with aneurysm folder; 3, participants with the metal foreign body in the eye; 4, pregnant women; 5, critically ill participants need life support systems; 6, epilepsy participants; 7, claustrophobic participants;. * participants who are \ 75 years. * participants who have the contraindication use of contrast media: glomerular filtration rate \<30 ml/min

Keywords: cardiomyopathy heart failure cardiac magnetic resonance
a study to evaluate the utilization, effectiveness, and quality of life of ozanimod in participants with ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to monitor the use, effectiveness and treatment persistence with ozanimod (zeposia®) as well as quality of life in participants undergoing treatment for moderate-to-severe ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * only ozanimod (zeposia®) naïve participants can be included into this prospective study * participants are suitable for therapy with ozanimod (zeposia®) according to the physician's recommendation (made before enrollment and independently of this non-interventional study (nis)) * treatment with ozanimod (zeposia®) must be in-label and follow the approved summary of product characteristics (smpc) * participants must have confirmed diagnosis of moderate-to-severe ulcerative colitis exclusion criteria: * participants that have previously been treated with ozanimod (zeposia®) * participants with mild ulcerative colitis (uc) * participants with a stoma * participants participating in other clinical trials * participants with a planned surgical intervention and hospitalization due to uc * participants with any contraindications specified in the current version of the smpc other protocol-defined inclusion/exclusion criteria apply.

Keywords: colitis, ulcerative zeposia ozanimod inflammatory bowel diseases
a study of intravenous aflibercept with docetaxel in chinese patients with solid tumors

Conditions: Neoplasm Malignant

Summary: primary objective: * to confirm the dose of aflibercept in western studies by assessing the dose-limiting toxicity (dlt) of intravenous (iv) aflibercept when administered in combination with docetaxel given intravenously every 3 weeks in chinese patients with solid tumors. secondary objectives: * to assess the safety profile of intravenous (iv) aflibercept when administered in combination with docetaxel * to determine the pharmacokinetics of iv aflibercept and docetaxel when administered in combination * to make a preliminary assessment of antitumor effects of the combination of docetaxel plus aflibercept in patients with evaluable disease * to evaluate the immunogenicity of iv aflibercept * to measure endogenous free vascular endothelial growth factor (vegf)

the duration of screening, treatment, and follow-up are within 21 days, 3 weeks/cycle, and 90 days after the last aflibercept administration. patients will be administered aflibercept in combination with docetaxel until when/if a definitive treatment discontinuation criterion is met such as progressive disease, unacceptable toxicity or patient refusal to continue.

Eligibility criteria:
inclusion criteria : * histologically or cytologically confirmed solid malignancy that metastatic or unresectable for which standard curative measures do not exist, but for which docetaxel treatment is appropriate. exclusion criteria : * squamous histology/cytology lung cancer * need for a major surgical procedure or radiation therapy during the study * treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days * cumulative radiation therapy to \>25% of the total bone marrow * history of brain metastases * eastern cooperative oncology group(ecog)\>1 * prior docetaxel treatment but have not been appropriate for safety reasons * inadequate organ and bone marrow function * uncontrolled hypertension * evidence of clinically significant bleeding diathesis or underlying coagulopathy the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
time-restricted feeding to reduce inflammation in fanconi anemia

Conditions: Fanconi Anemia

Summary: the main reason for this research study is to determine whether time-restricted eating will reduce inflammation in the bodies of persons with fanconi anemia (fa) and whether time-restricted eating will improve function in people with fa and neurological changes. participants will be asked to eat for only 8 hours out of 24 hours in a day.


Eligibility criteria:
inclusion criteria: * diagnosis of fa with neuroinflammation * age ≥ 12 years old exclusion criteria: * none
a multi-center, randomized, double masked, parallel-group, vehicle-controlled, clinical study to assess the safety and efficacy of reproxalap ophthalmic solution in subjects with dry eye disease

Conditions: Dry Eye Syndrome

Summary: a multi-center, phase 2b, randomized, double masked, parallel-group, vehicle-controlled, clinical study to assess the safety and efficacy of reproxalap ophthalmic solution (0.25% and 0.1%) compared to vehicle in subjects with dry eye disease


Eligibility criteria:
inclusion criteria: * be at least 18 years of age of either gender and any race; * have a reported history of dry eye for at least 6 months prior to visit 1; * have a history of use or desire to use eye drops for dry eye symptoms within 6 months of visit 1; exclusion criteria: * have any clinically significant slit lamp findings at visit 1 that may include active blepharitis, meibomian gland dysfunction (mgd), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; * have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses during the study; * have used any eye drops within 2 hours of visit 1; * have previously had laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; * have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of visit 1; * have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of visit 1; * be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of visit 1;

Keywords: reproxalap
a phase i/ii trial of idiotypic vaccination for chronic lymphocytic leukemia using a genetic approach

Conditions: Leukemia, Lymphocytic, Chronic

Summary: the goal of this clinical research study is learn if a vaccine that contains the patient's own cancer cell immunoglobulin can shrink or slow the growth of chronic lymphocytic leukemia (cll). this clinical trial is a dose escalation study in which the safety of this vaccine will be studied. this is a dose escalation study in which each patient will receive vaccine at one dose level. patients will be injected with a fragment of deoxyribonucleic acid (dna) containing the sequence of their own immunoglobulin gene. patients will be required to have their diagnosis of cll and stage confirmed prior to initiating vaccination. after vaccination patients will receive clinical and immunologic evaluation, including both humoral and cellular responses. the investigator will be assessing the patient's immune response or whether the patient's body recognizes the dna vaccine. in addition, side effects and reactions to the vaccine will be evaluated.

objectives: 1. to determine if patients with binet stage a cll generate an immune response to an antigen delivered by a dna vaccine. 2. to determine if patients with binet stage a cll generate an immune response to a tumor derived antigen delivered by a dna vaccine. 3. to determine the optimal dose of dna vaccine to obtain anti-idiotype immune responses. 4. to characterize any adverse effects of idiotypic vaccination with a dna vaccine. 5. to determine if dna idiotypic vaccination is capable of inducing remission in binet´s stage a cll.

Eligibility criteria:
inclusion criteria: * patients with binet stage a chronic lymphocytic leukemia (cll) * who performance status of 2 or less. * a life expectancy of at least one year. * greater than 18 years of age. * availability of cll cells which can be used for dna extraction and processing. * a platelet count greater than 100 x 109/l. * ability to provide full informed consent. exclusion criteria: * previous chemotherapy or radiotherapy. * presence of a monoclonal band on serum electrophoresis. * presence of clinically significant levels of anti-dna antibodies, anti-muscle antibodies or rheumatoid factors or who have active autoimmune disease. * presence of antibodies to human immunodeficiency virus (hiv) and known carriers of hepatitis b or hepatitis c virus. * presence of other serious medical condition e.g. congestive heart failure. * presence of other malignancies. * pregnancy, lactation, or not using contraceptive measures. * concurrent use of other anti-cancer therapy. * patients allergic to tetanus vaccine.

Keywords: chronic lymphocytic leukemia cll binet stage a vaccination idiotypic genetic deoxyribonucleic acid dna
cisplatin/paclitaxel/gemcitabine +/- avastin in patients with unknown primary tumor

Conditions: Unknown Primary Tumors

Summary: the purpose of this study is to investigate the efficacy of cisplatin, paclitaxel, gemcitabine +/- avastin (bevacizumab) in patients with unknown primary tumors.

upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms: arm a: cisplatin, paclitaxel and gemcitabine * cisplatin 75 mg/m2 iv infusion, day 1 * paclitaxel 175 mg/m2 iv infusion, day 1 * gemcitabine 1000 mg/m2 iv infusion, day 1 and 8 arm b: cisplatin, paclitaxel, gemcitabine and avastin (bevacizumab) * cisplatin 75 mg/m2 iv infusion, day 1 * paclitaxel 175 mg/m2 iv infusion, day 1 * gemcitabine 1000 mg/m2 iv infusion, day 1 and 8 * bevacizumab 7,5 mg/m2 iv infusion, day 1 patients will be stratified by number of metastatic sites (one versus two or more) and the level of lactate dehydrogenase (normal versus high). the regimens will be repeated every 21 days.

Eligibility criteria:
inclusion criteria: 1. unknown primary tumors 2. ecog performance status 0-1 3. adequate kidney, liver and bone marrow function 4. no prior chemotherapy 5. life expectancy \> 3 months exclusion criteria: 1. the following specific syndromes: * squamous carcinoma limited to cervical glands * women with adenocarcinoma isolated to axillary nodes * women with adenocarcinoma isolated to peritoneal involvements * young men (\<55 years) with growing mid-line tumors where a germ cell tumor could be expected * neuroendocrine carcinomas 2. tumor located close to major blood vessels and judged to possess a high risk of serious bleeding 3. any significant cardiac disease 4. clinically significant peripheral vascular disease 5. history of myocardial infarction or stroke within 6 months 6. evidence of coagulopathy 7. use of asa, nsaids or clopidogrel 8. pregnancy or breast feeding 9. ongoing therapeutic anti-coagulation 10. hypertension with blood pressure \> 150/100 mmhg 11. brain metastases
the results and outcomes of the modified swedish adjustable gastric band (sagb-vc)

Conditions: Weight Loss

Summary: since a few years the sagb-vc is used in our clinic. this type of band has a number of advantages when compared to the earlier versions of the adjustable gastric band (agb), reducing the chances on leakage, tube disconnection and port problems. in our clinic the follow up is strict. all patients are required to follow a special follow-up program in which the patient is seen 19 times during the first two years after sagb-vc placement. this is the first retrospective clinical study of a large study population of \>800 patients in which a sagb-vc was placed. this study was conducted to evaluate the results and the efficiency of the sagb-vc in our clinic.


Eligibility criteria:
inclusion criteria: * sagb band placed from 2004-2008 exclusion criteria: * none

Keywords: weight loss after sagb vc band placement
three methods for best peep determination compared with peep determination guided by adult respiratory distress syndrome (ards) network

Conditions: ARDS

Summary: to compare the best positive end expiratory pressure (peep) as determined by one of three commonly used clinical approaches for best peep determination, with peep guided by the ards network algorithm.

the determination of optimal level of positive end expiratory pressure (peep) in patients with acute hypoxemic respiratory pressure remains elusive and controversial. several approaches with different algorithms exist. among them, low peep algorithm approach and high peep algorithm approach. these approaches are characterized by a generalized application of certain level of peep according to a predefined algorithm. however, these algorithms fail to account for inter-individual variations between patients with different diseases and with different severities of the same underlying process. therefore, we advocate for an individualized application of peep. whereby, peep will be determined individually for each patient based on familiar and well established physiological parameters.

Eligibility criteria:
inclusion criteria: 20 man and women older than 18 years will be recruited. patients with acute respiratory failure of any cause who are mechanically ventilated according to the ards network recommendations will be considered for inclusion to the study. to be included in the study a prerequisite of high peak inspiratory pressure (plateau pressure of 25 to 30 cmh2o) has to be present, and at least one of the following four severity inclusion criteria has to be met. 1 - low total respiratory system compliance (ct), defined as less than 50ml/cmh2o. 2 - pao2 /fio2 ratio of less than 300. 3 - need for a peep greater than 10 cmh2o to maintain arterial oxygen saturation (sao2) of \> 90%. 4 - carbon dioxide partial pressure (pco2) over 60 mmhg, or ph less than 7.2 that is attributed to respiratory acidosis. exclusion criteria: patients with any of the following will be excluded from the study. previous lung or chest wall surgery, previous esophageal surgery, known achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoscoliosis.

Keywords: ards lung compliance
electroacupuncture for chronic neck pain

Conditions: Neck Pain

Summary: objective: the primary objective of this study is to evaluate the long-term efficacy of electroacupuncture for chronic neck pain. the secondary objective is to document any possible side effects of acupuncture. design and subjects: prospective, randomised controlled trial comparing the outcomes of treatment and placebo interventions. subjects are 200 adult patients with chronic mechanical neck pain. setting: outpatient clinics. interventions: patients will be randomly allocated to one of the two groups receiving either: electroacupuncture (real treatment) or placebo (sham laser acupuncture). each treatment will last for 45 minutes. each patient will receive a total of nine treatments (three times per week for three weeks). main outcome measures: primary outcome measures: neck pain disability index (northwick park neck pain questionnaire). secondary outcome measures: maximum pain related to motion on visual analogue scale. quality of life (sf-36). use of medication. sick leave because of neck pain. treatment-related adverse effects, such as pain, skin irritation, bleeding and dizziness, will also be assessed. assessments will be made before treatment, one month, three months and six months after the treatment course. the credibility of placebo treatment will also be assessed. expected results: we expect that patients in the treatment group will have significant improvements on primary and secondary outcome measures, when compared with patients in the inert placebo group. conclusion: this study will provide credible evidence regarding whether electroacupuncture is effective in reducing chronic neck pain. patients, healthcare professionals, and government policy makers can make use of this information to improve clinical outcomes and reduce costs


Eligibility criteria:
inclusion criteria: * adult male or female subjects age above 18 with mechanical neck pain for over three months. exclusion criteria: * patients who have received acupuncture treatment for any purpose in the last 6 months. * patients who will be unlikely to attend all treatment sessions. * patients with systemic diseases, such as diabetes or cardiovascular disorder. * patients with a history of traumatic injury of the neck or upper back from t1-t6, precious fracture or surgery to the neck, neurological deficits (e.g., muscle weakness or changes in spinal reflex jerks), a history of malignancy, congenital abnormality of the spine, or systemic bone and joint disorders (e.g., ra). * patients who are seeking compensation for neck-related condition. * patients who have needle phobia. * pregnant and breast feeding women.

Keywords: mechanical neck pain chronic acupuncture chronic mechanical neck pain